Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

NCT00163163 | Completed Phase 3

• 1 other identifier: A2581051
• Study Type: interventional
• Target: 400
• Locations: 3 countries
• Sites: 69

Brief Summary

To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.

Conditions

Hypercholesterolaemia

Outcome Measures

Primary Outcomes (1)

• Mean change in carotid IMT from baseline to month 12.

Secondary Outcomes (4)

• Mean change from baseline to month 12 of carotid internal diameter (ID)

• wall cross sectional area (WCSA); carotid arterial mass (AM)

• pulse pressure (PP); cross sectional distensibility and compliance (DC and CC)

• pulse wave velocity (PWV); Lipid profile

Interventions

Echographic measurements PROCEDURE

Blood samples PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women defined as having Age =\< 70 years with documented menopause
• Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =\< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet
• Triglycerides =\< 4 g/l(4.52 mmol/l)
• Informed, written consent

You may not qualify if:

• Age \> 70 years
• Unconfirmed menopause
• Overall duration of treatment with any HMG-CoA Reductase inhibitor \> 3 months within the last year
• Patient treated with any lipid-lowering drugs within the last 6 weeks preceding the randomization
• History of myocardial infarction, coronary bypass surgery, angioplasty, stroke or TIA
• CPK levels \> 3 times upper limit of normal
• Body Mass Index \>= 30

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (69)

Pfizer Investigational Site

Afsnee GENT, 9051, Belgium

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Pfizer Investigational Site

Assenede, 9960, Belgium

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Pfizer Investigational Site

Brussels, 1030, Belgium

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Pfizer Investigational Site

Brussels, 1050, Belgium

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Pfizer Investigational Site

Brussels, 1090, Belgium

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Pfizer Investigational Site

Brussels, 1180, Belgium

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Pfizer Investigational Site

Brussels, 1190, Belgium

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Pfizer Investigational Site

Ertvelde, 9940, Belgium

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Pfizer Investigational Site

Ghent, 9000, Belgium

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Pfizer Investigational Site

Linkebeek, 1630, Belgium

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Pfizer Investigational Site

Sint-Niklaas, 9100, Belgium

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Pfizer Investigational Site

Tielt, 8700, Belgium

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Pfizer Investigational Site

Wetteren, 9230, Belgium

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Pfizer Investigational Site

Wondelgem, 9032, Belgium

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Pfizer Investigational Site

Achenheim, 67204, France

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Pfizer Investigational Site

Ancerville, 55170, France

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Pfizer Investigational Site

Augny, 57685, France

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Pfizer Investigational Site

Bar-le-Duc, 55000, France

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Pfizer Investigational Site

Bois-Colombes, 92220, France

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Pfizer Investigational Site

Boissy-Saint-Léger, 94470, France

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Pfizer Investigational Site

Bouzonville, 57320, France

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Pfizer Investigational Site

Bœrsch, 67530, France

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Pfizer Investigational Site

Colombey-les-Belles, 54170, France

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Pfizer Investigational Site

Dammarie-les-Lys, 77190, France

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Pfizer Investigational Site

Docelles, 88460, France

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Pfizer Investigational Site

Dourdan, 91410, France

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Pfizer Investigational Site

Eckbolsheim, 67201, France

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Pfizer Investigational Site

Epinay S/orge, 91360, France

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Pfizer Investigational Site

Étampes, 91150, France

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Pfizer Investigational Site

Frouard, 54390, France

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Pfizer Investigational Site

Gambsheim, 67760, France

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Pfizer Investigational Site

Haguenau, 67500, France

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Pfizer Investigational Site

Kilstett, 67840, France

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Pfizer Investigational Site

Laxou, 54520, France

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Pfizer Investigational Site

Le Grand-Quevilly, 76120, France

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Pfizer Investigational Site

Le Mesnil-Esnard, 76240, France

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Pfizer Investigational Site

Leuville-sur-Orge, 91310, France

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Pfizer Investigational Site

Lingolsheim, 67380, France

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Pfizer Investigational Site

Longpont-sur-Orge, 91310, France

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Pfizer Investigational Site

Mars-la-Tour, 54800, France

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Pfizer Investigational Site

Metz, 57000, France

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Pfizer Investigational Site

Moûtiers, 54660, France

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Pfizer Investigational Site

Nancy, 54000, France

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Pfizer Investigational Site

Nancy, 5400, France

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Pfizer Investigational Site

Nancy, 54100, France

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Pfizer Investigational Site

Paris, 75008, France

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Pfizer Investigational Site

Paris, 75012, France

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Pfizer Investigational Site

Paris, 75015, France

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Pfizer Investigational Site

Paris, 75016, France

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Pfizer Investigational Site

Paris, 75017, France

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Pfizer Investigational Site

Pont-à-Mousson, 54700, France

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Pfizer Investigational Site

Pulnoy, 54420, France

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Pfizer Investigational Site

Rouen, 76100, France

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Pfizer Investigational Site

Saint-Max, 54130, France

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Pfizer Investigational Site

Sainte-Geneviève-des-Bois, 91700, France

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Pfizer Investigational Site

Sauvigny, 55140, France

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Pfizer Investigational Site

Savigny-sur-Orge, 91600, France

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Pfizer Investigational Site

Sotteville-lès-Rouen, 76308, France

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Pfizer Investigational Site

Souffelweyersheim, 67460, France

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Pfizer Investigational Site

Strasbourg, 67000, France

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Pfizer Investigational Site

Strasbourg, 67200, France

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Pfizer Investigational Site

Terville, 57180, France

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Pfizer Investigational Site

Toul, 54200, France

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Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54500, France

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Pfizer Investigational Site

Verdun, 55100, France

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Pfizer Investigational Site

Vincennes, 94300, France

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Pfizer Investigational Site

ED Voerendaal, 6367, Netherlands

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Pfizer Investigational Site

EN Vaals, 6291, Netherlands

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Pfizer Investigational Site

VE Maastricht, 6222, Netherlands

Location

Related Publications (1)

• Gompel A, Boutouyrie P, Joannides R, Christin-Maitre S, Kearny-Schwartz A, Kunz K, Laurent S, Boivin JM, Pannier B, Pornel B, Struijker-Boudier HA, Thuillez C, Van Bortel L, Zannad F, Pithois-Merli I, Jaillon P, Simon T. Association of menopause and hormone replacement therapy with large artery remodeling. Fertil Steril. 2011 Dec;96(6):1445-50. doi: 10.1016/j.fertnstert.2011.09.010. Epub 2011 Oct 6.

  PMID: 21982290 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: January 1, 2003
• Study Completion: July 1, 2006
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

BE (14); FR (52); NL (3)